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)

MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT

K-Number: K010779 · 2001-04-10

ApplicantGibbons Surgical Corp.
Decision Date2001-04-10
Product CodeFHO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Gibbons Surgical Corp.. It received FDA 510(k) clearance on 2001-04-10 under 510(k) number K010779. The device is classified under product code FHO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT?

MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT is a medical device that received FDA 510(k) clearance on 2001-04-10. The listed applicant is Gibbons Surgical Corp.. The 510(k) number is K010779.

When did MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT receive FDA 510(k) clearance?

MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT received FDA 510(k) clearance on 2001-04-10, under 510(k) number K010779.

Who is the listed applicant for MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT?

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

What is the FDA product code for MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT?

The FDA product code for MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT is FHO.

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 Gibbons Surgical 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.

K012198GIBBONS STERILE TROCAR KITS

Related Devices (Code: FHO)

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.

K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,LtdK121370VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLEVectecK970788PNEUMO-MATIC INSUFFLATION NEEDLEApple Medical Corp.K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMSherwood Medical Co.K951894ACCESS EXPANSION SYSTEMMicro-Medical Devices, Inc.K943624ELMED PNEUMOPERITONEUM NEEDLESHenke-Sass, Wolf GmbH

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.

↑