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FDA 510(k)

CONTINUOUS FLOW HYSTERO-RESECTOSCOPE

K-Number: K922420 · 1994-06-14

ApplicantLinvatec Corp.
Decision Date1994-06-14
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS FLOW HYSTERO-RESECTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1994-06-14 under 510(k) number K922420. 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 CONTINUOUS FLOW HYSTERO-RESECTOSCOPE?

CONTINUOUS FLOW HYSTERO-RESECTOSCOPE is a medical device that received FDA 510(k) clearance on 1994-06-14. The listed applicant is Linvatec Corp.. The 510(k) number is K922420.

When did CONTINUOUS FLOW HYSTERO-RESECTOSCOPE receive FDA 510(k) clearance?

CONTINUOUS FLOW HYSTERO-RESECTOSCOPE received FDA 510(k) clearance on 1994-06-14, under 510(k) number K922420.

Who is the listed applicant for CONTINUOUS FLOW HYSTERO-RESECTOSCOPE?

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

What is the FDA product code for CONTINUOUS FLOW HYSTERO-RESECTOSCOPE?

The FDA product code for CONTINUOUS FLOW HYSTERO-RESECTOSCOPE is HIH.

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Other records listing Linvatec Corp. as applicant

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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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