Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE

K-Number: K922711 · 1994-05-17

ApplicantOptimed Technologies, Inc.
Decision Date1994-05-17
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Optimed Technologies, Inc.. It received FDA 510(k) clearance on 1994-05-17 under 510(k) number K922711. 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 FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE?

FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1994-05-17. The listed applicant is Optimed Technologies, Inc.. The 510(k) number is K922711.

When did FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE receive FDA 510(k) clearance?

FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE received FDA 510(k) clearance on 1994-05-17, under 510(k) number K922711.

Who is the listed applicant for FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE?

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

What is the FDA product code for FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE?

The FDA product code for FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE is HIH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Optimed Technologies, 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.

K972520OPTIVIEWK955275BOOSTER TROPHY 5 MOTORIZED SCOOTERK955276BOOSTER LITE 4 MOTORIZED SCOOTERK955274BOOSTER LITE 3 MOTORIZED SCOOTERK943598FLEXIBLE FIBER OPTIC LAPAROSCOPESK926597LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

View all 15 devices →

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.

↑