Welch Allyn, Inc.
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including mounting bracket for Connex Spot Monitor Device (order CSM device separately), PanOptic Ophthalmoscope with…
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including mounting bracket for Connex Spot Monitor Device (order CSM device separately), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Vital Signs Accessory Basket, Vital Signs Monitor Power Supply (7000-PS), Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
1manufacturer
123catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | GCW |
| Device type | Transformer, Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K771864 |
| Record published | 2016-09-17 |
| Record revised | 2025-02-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 5 |
| Distribution end date | 2023-03-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901014 | 25 | In distribution | |
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | In distribution | ||
| 901027 | In distribution | ||
| 901067 | In distribution | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn | ||
| 901027 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transformer, Endoscope | Pentax of America, Inc. | 2 |
| Y/C cable | Olympus Medical Systems Corp. | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K771864 | 1977-11-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2025-03-21 | Class II | Device Design | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. | 135 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.