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)

STOMAHESIVE SKIN BARRIER STERILE

K-Number: K851840 · 1985-06-24

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1985-06-24
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STOMAHESIVE SKIN BARRIER STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1985-06-24 under 510(k) number K851840. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOMAHESIVE SKIN BARRIER STERILE?

STOMAHESIVE SKIN BARRIER STERILE is a medical device that received FDA 510(k) clearance on 1985-06-24. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K851840.

When did STOMAHESIVE SKIN BARRIER STERILE receive FDA 510(k) clearance?

STOMAHESIVE SKIN BARRIER STERILE received FDA 510(k) clearance on 1985-06-24, under 510(k) number K851840.

Who is the listed applicant for STOMAHESIVE SKIN BARRIER STERILE?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STOMAHESIVE SKIN BARRIER STERILE?

The FDA product code for STOMAHESIVE SKIN BARRIER STERILE is EXB.

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 Convatec, A Division of E.R. Squibb & Sons 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.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

View all 81 devices →

Related Devices (Code: EXB)

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.

K252140Heylo™ SystemColoplast Corp.K181643SmartBag (SmartPouch)11 Health Technologies LimitedK922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/SK880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.

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.

↑