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FDA 510(k)

INSUFFLATION NEEDLE, MODEL R65-933

K-Number: K000027 · 2000-04-03

ApplicantA & A Medical, Inc.
Decision Date2000-04-03
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFFLATION NEEDLE, MODEL R65-933 is the device name listed in this FDA 510(k) record. The listed applicant is A & A Medical, Inc.. It received FDA 510(k) clearance on 2000-04-03 under 510(k) number K000027. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUFFLATION NEEDLE, MODEL R65-933?

INSUFFLATION NEEDLE, MODEL R65-933 is a medical device that received FDA 510(k) clearance on 2000-04-03. The listed applicant is A & A Medical, Inc.. The 510(k) number is K000027.

When did INSUFFLATION NEEDLE, MODEL R65-933 receive FDA 510(k) clearance?

INSUFFLATION NEEDLE, MODEL R65-933 received FDA 510(k) clearance on 2000-04-03, under 510(k) number K000027.

Who is the listed applicant for INSUFFLATION NEEDLE, MODEL R65-933?

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

What is the FDA product code for INSUFFLATION NEEDLE, MODEL R65-933?

The FDA product code for INSUFFLATION NEEDLE, MODEL R65-933 is HIF.

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 A & A 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.

K013437SF SH CATHETER, MODEL R65-945K013491HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948K003949TACKER, MODEL R65-933K011512MMODIFICATION TO LAMINARIAK010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1K010789CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1

View all 23 devices →

Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems 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.

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