FDA 510(k)

CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400

K-Number: K991529 · 1999-09-14

Decision Date1999-09-14

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 is the device name listed in this FDA 510(k) record. The listed applicant is Conway Stuart Medical, Inc.. It received FDA 510(k) clearance on 1999-09-14 under 510(k) number K991529. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400?

CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 is a medical device that received FDA 510(k) clearance on 1999-09-14. The listed applicant is Conway Stuart Medical, Inc.. The 510(k) number is K991529.

When did CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 receive FDA 510(k) clearance?

CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 received FDA 510(k) clearance on 1999-09-14, under 510(k) number K991529.

Who is the listed applicant for CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400?

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

What is the FDA product code for CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400?

The FDA product code for CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 is GEI.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Conway Stuart Medical, Inc. as applicant

K000245CSM STRETTA SYSTEM K000170SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000 K992542TUBULAR ELECTRODE DEVICE K990724CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES K991291STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION K983986CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR

View all 10 devices →

Related Devices (Code: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., 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.