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FDA 510(k)

HAND EXTRACTOR HECTOR

K-Number: K953109 · 1995-08-25

ApplicantKarl Storz Endoscopy
Decision Date1995-08-25
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HAND EXTRACTOR HECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 1995-08-25 under 510(k) number K953109. 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 HAND EXTRACTOR HECTOR?

HAND EXTRACTOR HECTOR is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K953109.

When did HAND EXTRACTOR HECTOR receive FDA 510(k) clearance?

HAND EXTRACTOR HECTOR received FDA 510(k) clearance on 1995-08-25, under 510(k) number K953109.

Who is the listed applicant for HAND EXTRACTOR HECTOR?

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

What is the FDA product code for HAND EXTRACTOR HECTOR?

The FDA product code for HAND EXTRACTOR HECTOR is HIH.

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Other records listing Karl Storz Endoscopy 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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