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)

DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150

K-Number: K880951 · 1988-04-13

ApplicantAdvanced Surgical Products, Inc.
Decision Date1988-04-13
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Products, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K880951. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150?

DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Advanced Surgical Products, Inc.. The 510(k) number is K880951.

When did DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 receive FDA 510(k) clearance?

DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 received FDA 510(k) clearance on 1988-04-13, under 510(k) number K880951.

Who is the listed applicant for DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150?

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

What is the FDA product code for DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150?

The FDA product code for DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 is GXI.

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 Advanced Surgical Products, 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.

K030926FAST THROW STAINLESS STEEL SURGICAL SUTUREK895800ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATORK896754I/A HANDPIECEK896305MULTI-USE I/A HANDPIECEK884557ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECEK884556DREYER CURVED ENDOILLUMINATOR

View all 64 devices →

Related Devices (Code: GXI)

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.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., 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.

↑