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)

MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL

K-Number: K811087 · 1981-05-01

ApplicantCunningham Woodland, Inc.
Decision Date1981-05-01
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL is the device name listed in this FDA 510(k) record. The listed applicant is Cunningham Woodland, Inc.. It received FDA 510(k) clearance on 1981-05-01 under 510(k) number K811087. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL?

MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL is a medical device that received FDA 510(k) clearance on 1981-05-01. The listed applicant is Cunningham Woodland, Inc.. The 510(k) number is K811087.

When did MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL receive FDA 510(k) clearance?

MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL received FDA 510(k) clearance on 1981-05-01, under 510(k) number K811087.

Who is the listed applicant for MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL?

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

What is the FDA product code for MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL?

The FDA product code for MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL is FSM.

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 Cunningham Woodland, 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.

K823527SUBCLAVIAN INSERTION KITK813286PRE-PACK TENSK813519NON-ABSORBENT TOWELSK813284VENOUS CANNULA TRAYK811090MAJOR DRESSING TRAYK811088DRESSING TRAY MERCY HOSPITAL

View all 10 devices →

Related Devices (Code: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., 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.

↑