FDA 510(k)

HSW GMBH HYSTEROSCOPES & ACCESSORIES

K-Number: K952186 · 1996-02-06

Decision Date1996-02-06

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

HSW GMBH HYSTEROSCOPES & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Henke-Sass, Wolf GmbH. It received FDA 510(k) clearance on 1996-02-06 under 510(k) number K952186. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSW GMBH HYSTEROSCOPES & ACCESSORIES?

HSW GMBH HYSTEROSCOPES & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is Henke-Sass, Wolf GmbH. The 510(k) number is K952186.

When did HSW GMBH HYSTEROSCOPES & ACCESSORIES receive FDA 510(k) clearance?

HSW GMBH HYSTEROSCOPES & ACCESSORIES received FDA 510(k) clearance on 1996-02-06, under 510(k) number K952186.

Who is the listed applicant for HSW GMBH HYSTEROSCOPES & ACCESSORIES?

The FDA 510(k) record lists Henke-Sass, Wolf GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HSW GMBH HYSTEROSCOPES & ACCESSORIES?

The FDA product code for HSW GMBH HYSTEROSCOPES & ACCESSORIES is HIH.

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Other records listing Henke-Sass, Wolf GmbH as applicant

K173070HSW Resection Instruments K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath K101547HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)K943624ELMED PNEUMOPERITONEUM NEEDLES K941967HSW LAPAROSCOPE AND ACCESSORIES

Related Devices (Code: HIH)

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KG K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.

Official Source

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