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)

DOUBLE PUNCTURE INSTRUMENTS

K-Number: K852901 · 1985-10-16

ApplicantL.A.S.E.R., Inc.
Decision Date1985-10-16
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DOUBLE PUNCTURE INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is L.A.S.E.R., Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K852901. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOUBLE PUNCTURE INSTRUMENTS?

DOUBLE PUNCTURE INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is L.A.S.E.R., Inc.. The 510(k) number is K852901.

When did DOUBLE PUNCTURE INSTRUMENTS receive FDA 510(k) clearance?

DOUBLE PUNCTURE INSTRUMENTS received FDA 510(k) clearance on 1985-10-16, under 510(k) number K852901.

Who is the listed applicant for DOUBLE PUNCTURE INSTRUMENTS?

The FDA 510(k) record lists L.A.S.E.R., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOUBLE PUNCTURE INSTRUMENTS?

The FDA product code for DOUBLE PUNCTURE INSTRUMENTS is HET.

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 L.A.S.E.R., 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.

K983965CO2 LASER COUPLERK950021REUSABLE TROCAR WITH SAFETY SLEEVEK940454GRASPING FORCEPS, PUNCHES, SCISSORSK931561TROCAR SLEEVEK933421ENDOSCOPIC INSTRUMENTS AND ACCESSDORIESK924844BULK TISSUE REMOVAL SYSTEM

View all 14 devices →

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

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.

↑