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)

WALLACH INTEGRATION UNIT

K-Number: K963348 · 1997-03-19

ApplicantWallach Surgical Devices, Inc.
Decision Date1997-03-19
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WALLACH INTEGRATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Wallach Surgical Devices, Inc.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K963348. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLACH INTEGRATION UNIT?

WALLACH INTEGRATION UNIT is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K963348.

When did WALLACH INTEGRATION UNIT receive FDA 510(k) clearance?

WALLACH INTEGRATION UNIT received FDA 510(k) clearance on 1997-03-19, under 510(k) number K963348.

Who is the listed applicant for WALLACH INTEGRATION UNIT?

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

What is the FDA product code for WALLACH INTEGRATION UNIT?

The FDA product code for WALLACH INTEGRATION UNIT is HGI.

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 Wallach Surgical Devices, 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.

K021224ENDOCERVICAL BLOCK NEEDLEK020711WALLACH LOOP ELECTRODEK000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORK992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUMK991669PMS 750 FINGERSWITCHK983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)

View all 27 devices →

Related Devices (Code: HGI)

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.

K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLCK152843Liger Medical HTU-110Liger Medical, LLCK121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.K022593THOMAS MEDICAL ELECTRODESThomas Medical, 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.

↑