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)

MEDI GUARD DRAPES

K-Number: K911950 · 1991-05-21

ApplicantSancella, Inc.
Decision Date1991-05-21
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDI GUARD DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Sancella, Inc.. It received FDA 510(k) clearance on 1991-05-21 under 510(k) number K911950. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI GUARD DRAPES?

MEDI GUARD DRAPES is a medical device that received FDA 510(k) clearance on 1991-05-21. The listed applicant is Sancella, Inc.. The 510(k) number is K911950.

When did MEDI GUARD DRAPES receive FDA 510(k) clearance?

MEDI GUARD DRAPES received FDA 510(k) clearance on 1991-05-21, under 510(k) number K911950.

Who is the listed applicant for MEDI GUARD DRAPES?

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

What is the FDA product code for MEDI GUARD DRAPES?

The FDA product code for MEDI GUARD DRAPES is KME.

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 Sancella, 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.

K911944MEDI GUARD DENTAL BIBK911952MEDI GUARD UNDERPADK911953MEDI GUARD SHEETS/UNDERLAYSK911948MEDI GUARD PILLOWCASE

Related Devices (Code: KME)

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.

K042145READY-HEAT BLANKETTechtrade, LLCK944953OREX MEDICAL BEDDINGThantex Specialties, Inc.K933636DISPOSE-A-SHEETBelmac Healthcare Corp.K932539DOCTOR DOWN --RESCUE WRAPThree Dog DownK922143AMERICAN BURN SHEETAmerican Silk Sutures, Inc.K915303FOIL BABY BUNTINGGam Industries, 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.

↑