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)

NYLON COATED SPECULA

K-Number: K925501 · 1997-06-13

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1997-06-13
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NYLON COATED SPECULA is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K925501. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NYLON COATED SPECULA?

NYLON COATED SPECULA is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K925501.

When did NYLON COATED SPECULA receive FDA 510(k) clearance?

NYLON COATED SPECULA received FDA 510(k) clearance on 1997-06-13, under 510(k) number K925501.

Who is the listed applicant for NYLON COATED SPECULA?

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

What is the FDA product code for NYLON COATED SPECULA?

The FDA product code for NYLON COATED SPECULA is HIB.

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 Zinnanti Surgical Instruments, 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.

K941458UTERINE MANIPULATOR/INJECTOR WITH SPRINGK941457UTERINE INJECTOR WITH SPRINGK925560ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODESK925957SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USEK925960FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USEK926021NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE

View all 76 devices →

Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

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.

↑