Who else makes this device?

Name: Novo Surgical Inc.
Brand: Novo Surgical Inc.

Ophthalmic › SurgicalCystotome

Novo Surgical Inc.

kelman cystotome knife cannula, sharp edge, 22 gauge shaft, 1.3" (3.2 cm)

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code HNY
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Xinhua Surgical Instrument Co., Ltd.	Zibo	Shandong	Manufacturer	222

Record

Regulatory record for Novo Surgical Inc.
Listed by	Novo Surgical, Inc., United States
FDA product code	HNY
Device type	Cystotome
Device class	Class 1
Regulation	21 CFR 886.4350
Establishment	Repacker / relabeller
Premarket notification	Exempt
Record published	2022-11-13

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Novo Surgical Inc.
Catalogue number	Size	Status
OP7121-33B		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Anodyne Surgical	Psi/Eye-Ko, Inc.	106
MSI Precision Specialty Instruments	MED Saver, Inc.	32
Visitec®	Beaver-Visitec International, Ltd	32
Walcott Rx Products	Psi/Eye-Ko, Inc.	30
Disposable Instruments	Oasis Medical, Inc.	26
Ambler Surgical	Ambler Surgical, LLC	25
Alcon	Alcon Laboratories, Inc.	16
Blink	Katena Products, Inc.	14
Irrigating Cystotome	Hurricane Medical	11
Oph. Cystotomes	Katena Products, Inc.	9
Millennium	Avalign Technologies, Inc.	6
Cystotome	Katena Products, Inc.	6

Showing 12 of 45. All products under Cystotome

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.