FDA 510(k)

MEGA GENERAL PURPOSE INSTRUMENT KIT

K-Number: K910366 · 1991-03-28

ApplicantMegadyne Medical Products, Inc.

Decision Date1991-03-28

Product CodeKDD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEGA GENERAL PURPOSE INSTRUMENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 1991-03-28 under 510(k) number K910366. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGA GENERAL PURPOSE INSTRUMENT KIT?

MEGA GENERAL PURPOSE INSTRUMENT KIT is a medical device that received FDA 510(k) clearance on 1991-03-28. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K910366.

When did MEGA GENERAL PURPOSE INSTRUMENT KIT receive FDA 510(k) clearance?

MEGA GENERAL PURPOSE INSTRUMENT KIT received FDA 510(k) clearance on 1991-03-28, under 510(k) number K910366.

Who is the listed applicant for MEGA GENERAL PURPOSE INSTRUMENT KIT?

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

What is the FDA product code for MEGA GENERAL PURPOSE INSTRUMENT KIT?

The FDA product code for MEGA GENERAL PURPOSE INSTRUMENT KIT is KDD.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Megadyne Medical Products, Inc. as applicant

K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)K213696ETHICON Megadyne Electrosurgical Generator K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor K193145Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch K191328Megadyne Foot Switch K080741MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE

View all 48 devices →

Related Devices (Code: KDD)

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidien K011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K936255CUSTOM CV PACKAssociated Medical K932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products 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.