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)

MITEK SNAP PAK(TM), MODIFICATION

K-Number: K915081 · 1992-01-31

ApplicantMitek Surgical Products, Inc.
Decision Date1992-01-31
Product CodeGAS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MITEK SNAP PAK(TM), MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Surgical Products, Inc.. It received FDA 510(k) clearance on 1992-01-31 under 510(k) number K915081. The device is classified under product code GAS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITEK SNAP PAK(TM), MODIFICATION?

MITEK SNAP PAK(TM), MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Mitek Surgical Products, Inc.. The 510(k) number is K915081.

When did MITEK SNAP PAK(TM), MODIFICATION receive FDA 510(k) clearance?

MITEK SNAP PAK(TM), MODIFICATION received FDA 510(k) clearance on 1992-01-31, under 510(k) number K915081.

Who is the listed applicant for MITEK SNAP PAK(TM), MODIFICATION?

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

What is the FDA product code for MITEK SNAP PAK(TM), MODIFICATION?

The FDA product code for MITEK SNAP PAK(TM), MODIFICATION is GAS.

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 Mitek Surgical Products, 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.

K953560MITEK THREADED ANCHOR (FASTIN)K953877MITEK GII ANCHORK936311MITEK MINI ANCHORK941599MITEK ABSORBABLE ANCHORK944051ABSORBALBE ANCHORK950070MITEK TOGGLE ANCHOR(TM)

View all 31 devices →

Related Devices (Code: GAS)

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.

K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneLsi Solutions, Inc.K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi SolutionsK091018ARTHREX BIOWIREArthrex, Inc.K002261MR-IIISmith & Nephew, Inc.K953128SUTURE CORDPhoenix Biomedical Corp.K923161BRAIDED POLYESTER SUTURE MATERIALMitek Surgical Products, 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.

↑