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)

SPACE-OR RETRACTOR

K-Number: K993544 · 1999-12-22

ApplicantAdvanced Surgical Concepts (Asc)
Decision Date1999-12-22
Product CodeFFO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPACE-OR RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Concepts (Asc). It received FDA 510(k) clearance on 1999-12-22 under 510(k) number K993544. The device is classified under product code FFO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACE-OR RETRACTOR?

SPACE-OR RETRACTOR is a medical device that received FDA 510(k) clearance on 1999-12-22. The listed applicant is Advanced Surgical Concepts (Asc). The 510(k) number is K993544.

When did SPACE-OR RETRACTOR receive FDA 510(k) clearance?

SPACE-OR RETRACTOR received FDA 510(k) clearance on 1999-12-22, under 510(k) number K993544.

Who is the listed applicant for SPACE-OR RETRACTOR?

The FDA 510(k) record lists Advanced Surgical Concepts (Asc) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPACE-OR RETRACTOR?

The FDA product code for SPACE-OR RETRACTOR is FFO.

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 Advanced Surgical Concepts (Asc) 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.

K011183OMNIPORT HAND AND INSTRUMENT ACCESS DEVICEK010711ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTORK002013OMNIPORT

Related Devices (Code: FFO)

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.

K870897KODNER ANAL PERIONEAL RETRACTORSur-Med Instruments, Inc.K860368URDYN 5000 (UROFLOWMETER)Dantec Electronics, Inc.K853119URODYN 1000Dantec Electronics, Inc.K852083THE KENDALL URINARY OUTPUT MONITORThe Kendal Co.

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.

↑