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FDA 510(k)

HYSTEROSCOPE

K-Number: K954164 · 1996-03-12

ApplicantConceptus, Inc.
Decision Date1996-03-12
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Conceptus, Inc.. It received FDA 510(k) clearance on 1996-03-12 under 510(k) number K954164. 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 HYSTEROSCOPE?

HYSTEROSCOPE is a medical device that received FDA 510(k) clearance on 1996-03-12. The listed applicant is Conceptus, Inc.. The 510(k) number is K954164.

When did HYSTEROSCOPE receive FDA 510(k) clearance?

HYSTEROSCOPE received FDA 510(k) clearance on 1996-03-12, under 510(k) number K954164.

Who is the listed applicant for HYSTEROSCOPE?

The FDA 510(k) record lists Conceptus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYSTEROSCOPE?

The FDA product code for HYSTEROSCOPE is HIH.

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Other records listing Conceptus, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974028STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBINGK972210RESECTOSCOPE SAFETY SHEATHK962587CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEMK953314CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEMK932387CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDRELK932993INTRAUTERINE CATHETER AND INTRODUCER

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Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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. KGK261102UNIDRIVE Select SystemKarl Storz SE & CO. KGK254294Single-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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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