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FDA 510(k)

SAFETEX CERVICAL SCRAPER (PLASTIC)

K-Number: K983428 · 1998-11-16

ApplicantAndwin Scientific
Decision Date1998-11-16
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SAFETEX CERVICAL SCRAPER (PLASTIC) is the device name listed in this FDA 510(k) record. The listed applicant is Andwin Scientific. It received FDA 510(k) clearance on 1998-11-16 under 510(k) number K983428. 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 SAFETEX CERVICAL SCRAPER (PLASTIC)?

SAFETEX CERVICAL SCRAPER (PLASTIC) is a medical device that received FDA 510(k) clearance on 1998-11-16. The listed applicant is Andwin Scientific. The 510(k) number is K983428.

When did SAFETEX CERVICAL SCRAPER (PLASTIC) receive FDA 510(k) clearance?

SAFETEX CERVICAL SCRAPER (PLASTIC) received FDA 510(k) clearance on 1998-11-16, under 510(k) number K983428.

Who is the listed applicant for SAFETEX CERVICAL SCRAPER (PLASTIC)?

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

What is the FDA product code for SAFETEX CERVICAL SCRAPER (PLASTIC)?

The FDA product code for SAFETEX CERVICAL SCRAPER (PLASTIC) 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

Other records listing Andwin Scientific 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.

K983599SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KITK964698SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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