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FDA 510(k)

INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM

K-Number: K081070 · 2008-07-23

ApplicantInterlace Medical, Inc.
Decision Date2008-07-23
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Interlace Medical, Inc.. It received FDA 510(k) clearance on 2008-07-23 under 510(k) number K081070. 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 INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM?

INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Interlace Medical, Inc.. The 510(k) number is K081070.

When did INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM receive FDA 510(k) clearance?

INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM received FDA 510(k) clearance on 2008-07-23, under 510(k) number K081070.

Who is the listed applicant for INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM?

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

What is the FDA product code for INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM?

The FDA product code for INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM is HIH.

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Other records listing Interlace Medical, 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.

K103741SURGISURE TISSUE REMOVAL SYSTEMK102686MYOSURE ROD LENS SCOPE SEALSK100559MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMK091100MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMK091465MYOSURE ROD LENS HYSTEROSCOPEK073690INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM

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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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