FDA 510(k)

CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)

K-Number: K121441 · 2012-07-20

Decision Date2012-07-20

Product CodeHQP

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2012-07-20 under 510(k) number K121441. The device is classified under product code HQP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)?

CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) is a medical device that received FDA 510(k) clearance on 2012-07-20. The listed applicant is Bovie Medical Corporation. The 510(k) number is K121441.

When did CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) receive FDA 510(k) clearance?

CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) received FDA 510(k) clearance on 2012-07-20, under 510(k) number K121441.

Who is the listed applicant for CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)?

The FDA 510(k) record lists Bovie Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)?

The FDA product code for CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) is HQP.

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 Bovie Medical Corporation as applicant

K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces K170777Bovie J-Plasma Precise FLEX Handpiece K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator K152777Bovie Disposable Bipolar Ablator

View all 10 devices →

Related Devices (Code: HQP)

K083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERYFiab Spa K062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIESKirwan Surgical Products, Inc.K023506SURGICAL MEDICAL DEVICE CAUTERYModern Medical Equipment Mfg., Ltd.K002547STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTORStarion Instruments K994019CAUTERY GRASPER/DISSECTORStarion Instruments K990728THERMAL CAUTERY DEVICE, FORCEPSStarion Instruments

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.