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FDA 510(k)

RG27-SERIES RESECTOSCOPE AND ACCESSORIES

K-Number: K914108 · 1992-03-19

ApplicantCooperSurgical, Inc.
Decision Date1992-03-19
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RG27-SERIES RESECTOSCOPE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 1992-03-19 under 510(k) number K914108. 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 RG27-SERIES RESECTOSCOPE AND ACCESSORIES?

RG27-SERIES RESECTOSCOPE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1992-03-19. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K914108.

When did RG27-SERIES RESECTOSCOPE AND ACCESSORIES receive FDA 510(k) clearance?

RG27-SERIES RESECTOSCOPE AND ACCESSORIES received FDA 510(k) clearance on 1992-03-19, under 510(k) number K914108.

Who is the listed applicant for RG27-SERIES RESECTOSCOPE AND ACCESSORIES?

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

What is the FDA product code for RG27-SERIES RESECTOSCOPE AND ACCESSORIES?

The FDA product code for RG27-SERIES RESECTOSCOPE AND ACCESSORIES is HIH.

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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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