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)

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

K-Number: K926597 · 1994-07-12

ApplicantOptimed Technologies, Inc.
Decision Date1994-07-12
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) 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 1994-07-12 under 510(k) number K926597. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)?

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Optimed Technologies, Inc.. The 510(k) number is K926597.

When did LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) receive FDA 510(k) clearance?

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) received FDA 510(k) clearance on 1994-07-12, under 510(k) number K926597.

Who is the listed applicant for LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)?

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 LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)?

The FDA product code for LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) is HET.

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 LAPAROSCOPESK921942HYSTEROSCOPE (AND ACCESSORIES)

View all 15 devices →

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , 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.

↑