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FDA 510(k)

SABRE BT BLUNT0TIP SURGICAL TROCAR

K-Number: K980804 · 1998-04-01

ApplicantEndoscopic Concepts, Inc.
Decision Date1998-04-01
Product CodeFBQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SABRE BT BLUNT0TIP SURGICAL TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Concepts, Inc.. It received FDA 510(k) clearance on 1998-04-01 under 510(k) number K980804. The device is classified under product code FBQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SABRE BT BLUNT0TIP SURGICAL TROCAR?

SABRE BT BLUNT0TIP SURGICAL TROCAR is a medical device that received FDA 510(k) clearance on 1998-04-01. The listed applicant is Endoscopic Concepts, Inc.. The 510(k) number is K980804.

When did SABRE BT BLUNT0TIP SURGICAL TROCAR receive FDA 510(k) clearance?

SABRE BT BLUNT0TIP SURGICAL TROCAR received FDA 510(k) clearance on 1998-04-01, under 510(k) number K980804.

Who is the listed applicant for SABRE BT BLUNT0TIP SURGICAL TROCAR?

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

What is the FDA product code for SABRE BT BLUNT0TIP SURGICAL TROCAR?

The FDA product code for SABRE BT BLUNT0TIP SURGICAL TROCAR is FBQ.

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 Endoscopic Concepts, 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.

K952977SABRE MULTI-USE TROCAR SYSTEMK950500BASIC REUSABLE TROCAR SYSTEMK943976SABRE ULTIMATE SHIELDED TROCAR

Related Devices (Code: FBQ)

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 KITSGibbons Surgical Corp.K944640LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITGabris Surgical Corp.K944104GABRIS LAPAROSCOPIC SURGICAL KITSGabris Surgical Corp.K942885AUTO SUTURE MODIFIED GRIPUnited States Surgical, A Division of Tyco HealthcK934724AESCULAP TROCAR INSTRUMENT SETAesculap, Inc.K904638TROCAR DISPOSABLEL.A.S.E.R., Inc.

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.

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