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)

KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES

K-Number: K962985 · 1997-12-19

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1997-12-19
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K962985. 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 KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES?

KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K962985.

When did KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES receive FDA 510(k) clearance?

KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES received FDA 510(k) clearance on 1997-12-19, under 510(k) number K962985.

Who is the listed applicant for KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES?

The FDA product code for KSEA C.C.L. VAGINAL EXTRACTOR 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 KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

View all 355 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.

↑