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FDA 510(k)

GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT

K-Number: K954562 · 1995-12-22

ApplicantGynetech, Inc.
Decision Date1995-12-22
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gynetech, Inc.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K954562. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT?

GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Gynetech, Inc.. The 510(k) number is K954562.

When did GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT receive FDA 510(k) clearance?

GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT received FDA 510(k) clearance on 1995-12-22, under 510(k) number K954562.

Who is the listed applicant for GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT?

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

What is the FDA product code for GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT?

The FDA product code for GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT is HHT.

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

Related Devices (Code: HHT)

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.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, 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.

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