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FDA 510(k)

FIBER OPTIC LIGHT SOURCE

K-Number: K812202 · 1981-09-29

ApplicantReznik Instruments
Decision Date1981-09-29
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FIBER OPTIC LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Reznik Instruments. It received FDA 510(k) clearance on 1981-09-29 under 510(k) number K812202. 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 FIBER OPTIC LIGHT SOURCE?

FIBER OPTIC LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Reznik Instruments. The 510(k) number is K812202.

When did FIBER OPTIC LIGHT SOURCE receive FDA 510(k) clearance?

FIBER OPTIC LIGHT SOURCE received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812202.

Who is the listed applicant for FIBER OPTIC LIGHT SOURCE?

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

What is the FDA product code for FIBER OPTIC LIGHT SOURCE?

The FDA product code for FIBER OPTIC LIGHT SOURCE is HIH.

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Other records listing Reznik Instruments 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.

K812205FORCEPK812201PHOTOGRAPHIC EQUIPMENTK812204UTERINE MANIPULATORSK812203ELECTROSURGICAL UNITK812199TROCAR & TROCAR SLEEVESK812206LAPAROSCOPE

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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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