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)

SPENCO DERMAL PADS

K-Number: K811184 · 1981-05-20

ApplicantSpenco Medical Corp.
Decision Date1981-05-20
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPENCO DERMAL PADS is the device name listed in this FDA 510(k) record. The listed applicant is Spenco Medical Corp.. It received FDA 510(k) clearance on 1981-05-20 under 510(k) number K811184. The device is classified under product code FMP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPENCO DERMAL PADS?

SPENCO DERMAL PADS is a medical device that received FDA 510(k) clearance on 1981-05-20. The listed applicant is Spenco Medical Corp.. The 510(k) number is K811184.

When did SPENCO DERMAL PADS receive FDA 510(k) clearance?

SPENCO DERMAL PADS received FDA 510(k) clearance on 1981-05-20, under 510(k) number K811184.

Who is the listed applicant for SPENCO DERMAL PADS?

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

What is the FDA product code for SPENCO DERMAL PADS?

The FDA product code for SPENCO DERMAL PADS is FMP.

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 Spenco Medical 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.

K981902SPENCO SILICONE GEL SHEETK9222282ND SKIN STERILE ADHESIVE STRIPK9115502ND SKIN MOIST BURN PADS WITH ALOEK910927SPENCIO SKIN GUARD KITK896533SPENCO BREAST FORMSK8948982ND SKIN NON-STICK MOIST BURN PADS

View all 10 devices →

Related Devices (Code: FMP)

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.

K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.K934731MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.K812344HEEL OR ELBOW PROTECTORFred Sammons, Inc.K802829SCANLAN VASCU-STATTScanlan Intl., Inc.K802185ARTERIAL BLOOD SAMPLING KITCurrent Technologies, 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.

↑