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)

SILICONE GEL SHEETING

K-Number: K932048 · 1994-01-07

ApplicantSilipos, Inc.
Decision Date1994-01-07
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILICONE GEL SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Silipos, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K932048. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE GEL SHEETING?

SILICONE GEL SHEETING is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Silipos, Inc.. The 510(k) number is K932048.

When did SILICONE GEL SHEETING receive FDA 510(k) clearance?

SILICONE GEL SHEETING received FDA 510(k) clearance on 1994-01-07, under 510(k) number K932048.

Who is the listed applicant for SILICONE GEL SHEETING?

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

What is the FDA product code for SILICONE GEL SHEETING?

The FDA product code for SILICONE GEL SHEETING is MDA.

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 Silipos, 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.

K955664STERILIZED TRI BLOCK POLYMER GEL SHEETK944240SOFT SOCKK942695TRI BLOCK POLUMER GEL SHEETING

Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson 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.

↑