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)

PARAMETRIC STERILITY RELEASE OF AUTO

K-Number: K830741 · 1983-08-11

ApplicantUnited Surgical Corp.
Decision Date1983-08-11
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARAMETRIC STERILITY RELEASE OF AUTO is the device name listed in this FDA 510(k) record. The listed applicant is United Surgical Corp.. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K830741. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMETRIC STERILITY RELEASE OF AUTO?

PARAMETRIC STERILITY RELEASE OF AUTO is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is United Surgical Corp.. The 510(k) number is K830741.

When did PARAMETRIC STERILITY RELEASE OF AUTO receive FDA 510(k) clearance?

PARAMETRIC STERILITY RELEASE OF AUTO received FDA 510(k) clearance on 1983-08-11, under 510(k) number K830741.

Who is the listed applicant for PARAMETRIC STERILITY RELEASE OF AUTO?

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

What is the FDA product code for PARAMETRIC STERILITY RELEASE OF AUTO?

The FDA product code for PARAMETRIC STERILITY RELEASE OF AUTO is GAG.

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 United Surgical Corp. 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.

K902150PIEZO HANDPIECEK870671PHACOTRON DAY PAKK870806NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100K870194UNITED SURGICAL CORP. DIATHERMIC PLUSK870195UNITED SURGICAL CORP. CRYOPTIC PLUSK860014SYSTEMS PLUS

View all 7 devices →

Related Devices (Code: GAG)

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.

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLCK251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLCK234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington 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.

↑