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)

FORCEPS, BIOPSY, NON-ELECTRIC

K-Number: K952863 · 1995-07-19

ApplicantAnnex Medical, Inc.
Decision Date1995-07-19
Product CodeFCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FORCEPS, BIOPSY, NON-ELECTRIC is the device name listed in this FDA 510(k) record. The listed applicant is Annex Medical, Inc.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K952863. The device is classified under product code FCL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORCEPS, BIOPSY, NON-ELECTRIC?

FORCEPS, BIOPSY, NON-ELECTRIC is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Annex Medical, Inc.. The 510(k) number is K952863.

When did FORCEPS, BIOPSY, NON-ELECTRIC receive FDA 510(k) clearance?

FORCEPS, BIOPSY, NON-ELECTRIC received FDA 510(k) clearance on 1995-07-19, under 510(k) number K952863.

Who is the listed applicant for FORCEPS, BIOPSY, NON-ELECTRIC?

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

What is the FDA product code for FORCEPS, BIOPSY, NON-ELECTRIC?

The FDA product code for FORCEPS, BIOPSY, NON-ELECTRIC is FCL.

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 Annex 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.

K954377FORCEPS, GRASPING, FLEXIBLE ENDOSCOPICK951532METAL URETERAL BASKET STONE DISLODGERK951761METEL URETERAL BASKET STONE DISLODGERK934636ANNEX MEDICAL FLAT WIRE STONE EXTRACTORK934675METAL URETERAL BASKET STONE DISLODGERK934598GRASPING FORCEPS OR RETRIEVAL FORCEPS

View all 23 devices →

Related Devices (Code: FCL)

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.

K032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEOlympus Optical Co., Ltd.K973611SPECTRASCIENCE REUSABLE BIOPSY FORCEPSSpectrascience, Inc.K971315AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.K964120INJECTO FLUSHRobert J. Jynch, Jr.K963517SPECTRA SCIENCE BIOPSY FORCEPSSpectrascience, Inc.K955065OLYMPUS FB SERIES BIOPSY FORCEPSOlympus America, Inc.

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.

↑