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)

SLT BIPOLAR SHEATH

K-Number: K981041 · 1998-08-27

ApplicantSurgical Laser Technologies, Inc.
Decision Date1998-08-27
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SLT BIPOLAR SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Laser Technologies, Inc.. It received FDA 510(k) clearance on 1998-08-27 under 510(k) number K981041. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLT BIPOLAR SHEATH?

SLT BIPOLAR SHEATH is a medical device that received FDA 510(k) clearance on 1998-08-27. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K981041.

When did SLT BIPOLAR SHEATH receive FDA 510(k) clearance?

SLT BIPOLAR SHEATH received FDA 510(k) clearance on 1998-08-27, under 510(k) number K981041.

Who is the listed applicant for SLT BIPOLAR SHEATH?

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

What is the FDA product code for SLT BIPOLAR SHEATH?

The FDA product code for SLT BIPOLAR SHEATH is ERL.

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 Surgical Laser Technologies, 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.

K042211MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMSK023624SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921K011409SLT LASERPRO CTH HOLMIUM LASER SYSTEMK010041SLT DIFFUSER FIBERK984018HEMOSLEEVE, MODEL 4.0MM, 5.5MMK983050PNEUMATIC CUTTER SYSTEM

View all 51 devices →

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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.

↑