Probe, Ent

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Shandong, Shanghai and Zhejiang: 3 hold an FDA registration.

Hangzhou Haizhu MIM Products Co., Ltd. Zhejiang
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

What Is FDA Product Code KAK?

Probe, Ent is FDA product code KAK, Class 1, 21 CFR 874.4420.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2012. None was by a company in China. The root cause the FDA records most often is Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Nasal Probe

s-shaped, bendable 17.5 cm

Probe, Ent

PROBE DULL TL 265MM angled

Tube Probe

rounded ends Ø 0.6 mm, 40 cm

Susol® Probe Jobson-Horne 18cm (Pack of 25) Non Sterile

Catalogue number SS21-2030M, listed by Bailey Instruments Ltd, United Kingdom, under Probe, Ent. 3 manufacturers in China are registered for this product code.

Jobson Horne Probe 178mm (7inch)

2 catalogue numbers from JHPL10001-S, listed by DTR Medical Ltd, United Kingdom, under Probe, Ent. 3 manufacturers in China are registered for this product code.

Integra® Miltex®

Integra® Miltex® Buck Ear Probe 5-1/2"

Ball-End Probe

bayonet, probe angled 9.5 mm, 24 cm

Adler Instrument Company

OStium Seeker Ball ENd D/E 7-1/2

Novo Surgical

jako laryngeal probe, length, working: 8-5/8" (22.0 cm), overall: 11-5/8" (30.0 cm), angled

Symmetry Skillern

Symmetry® Probe, Skillern Sinus, 6 1/2 in

6 Michigan O Expro, Periodontal Probe

Catalogue number PP006, listed by Berman Instruments LLC, under Probe, Ent. 3 manufacturers in China are registered for this product code.

Endolaryngeal Probe

Endolaryngeal Probe Microscopic Straight Button-END

Integra® Jarit®

Integra® Jarit® Buck Ear Probe 5-1/2"

Lighted Magnetic Foreign Body Removal Tool

Lighted Magnetic Foreign Body Remover - 1ct

Probe, Blunt

straight WL 20 cm

Probe, Ent

CERAMO RHOTON nerve hook, ball pointed, angled, 190 mm

Frontal Sinus Seeker

double ended, strongly curved - 90° 22 cm

#23/CP-12 Color Coded Explorer, Periodontal Probe

Catalogue number PX312, listed by Berman Instruments LLC, under Probe, Ent. 3 manufacturers in China are registered for this product code.

Symmetry Jako

Symmetry® Probe, Jako Laryngeal, Straight, 11 5/8 in

Intrace USA

Jobson Horne Probe, 140mm Overall Length, Double-Ended with Ring Tip and Serrated Probe End, Stainless Steel, Reusable.

Hollow Probe

straight 14.5 cm

Adept Medical

Jobson Horne Probes NON-Ster PK/100

Aesculap

Probe, curved, 8 3/4" (220 mm), double ended, probe tip, non-sterile - autoclavable

Probe

Catalogue number 99-534-98-01, listed by KLS-Martin L.P., United States, under Probe, Ent. 3 manufacturers in China are registered for this product code.

Salivary Duct Probe Set, Double Ended

bendable, nitinol, 6 sizes

Grooved Director 130mm

Catalogue number GDR2001, listed by DTR Medical Ltd, United Kingdom, under Probe, Ent. 3 manufacturers in China are registered for this product code.

V. Mueller

V. Mueller ARBUCKLE SINUS PROBE DELICATE, MALLEABLE SILVER WORKING LENGTH 8" (20.3CM)

Jobson Horne Probe 127mm (5 Inch)

2 catalogue numbers from JHPS5001-S, listed by DTR Medical Ltd, United Kingdom, under Probe, Ent. 3 manufacturers in China are registered for this product code.

V. Mueller

V. Mueller JAKO LARYNGEAL PROBE STRAIGHT WORKING LENGTH 8-5/8 inches 22CM OVERALL LENGTH 11-5/8 inches 29.5CM

Bear

Claire Ear Hook, 90 Degree Tips, 2.5 and 3.0mm

Bausch + Lomb

Probe Sinus Skillern Graduated

RZ Medizintechnik GmbH

AUSTIN Measuring probe(caliper)determine length of stapes prosthesis, 6 1/4" 160 mm, markings at 3.5 - 4.0 - 4.5 mm

Salivary Duct Probe

straight, cylindrical 0.8 mm diameter

Symmetry Ostium

Symmetry® Seeker, Ostium, w/Double-Ended Ball Tips Frontal Sinus One End 90°

Bear

Ostium Seeker, Double-Ended, Maxillary

MSI Precision Specialty Instruments

Kuhn Bolenger Frontal Ostium Seeker, Double Ended, Curved Shafts, One Ball End Angled 90 Degrees, Other Ball End Not Angled, Round Handle, Overall Length 7-5/8" (194mm)

Novo Surgical Inc.

frontal sinus seeker, double ended, #2, both sides curved 90 degrees, one tip straight, one tip reverse angled, 22cm length

Micro Hook

forward/backward, blunt, straight 21.5 cm

Avalign

Jako Laryngeal Probe, straight,

Medicon

Stacke Frenzel ear probe ang 10cm sterling silver

Integra®

Integra® Jako Laryngeal Probe, Straight

Inka

Frontal Ostium Seeker Probe double-ended one tip 90° ball tips 1.2mm / 1.5mm 21cm

Maxillary Sinus Seeker

double ended, 19 cm

Bowman Salivary Duct Probe

alpaca, size 3/4, 1.3 a. 1.4 mm straight, cylindrical, 13 cm

Jedmed

Probe Blunt Straight 20CM WRK Lngth

Pilling

Lumen Finder 14 French

Millennium

Allport Incus Hook Angled 90 Degrees, Tip 3mm Length, Not a Ball Tip, OL 9"

Mytamed

Claire Ear Hook, 90 Degree Tips, 1.5 and 2.0mm

BR Surgical, LLC

Frontal Sinus Seeker #6, double-ended, #2, straight & reverse angle tip 90 degree (both sides), 8 1/2"

Ambler Surgical

Frontal ostium seeker, 7 5/8'', double-ended, curved, ball tips, one end at 90 degrees, hexagonal handle

Fentex

Frontal Sinus Seeker by Kuhn double-ended, both sides curved 90° 22 cm, Fig. 2

HNM Medical

00842962108734 HNM-1-09-0514 Probe, 5 1/2", Double Ended, SS KAK D181658 47862

MicroFrance®

MicroFrance® Wormald malleable suction tube with finger control, 3.5 mm diameter, 175 mm length

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer