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)

J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS

K-Number: K953655 · 1995-10-13

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1995-10-13
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K953655. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS?

J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K953655.

When did J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS receive FDA 510(k) clearance?

J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS received FDA 510(k) clearance on 1995-10-13, under 510(k) number K953655.

Who is the listed applicant for J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS?

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

What is the FDA product code for J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS?

The FDA product code for J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS is OCX.

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 Johnson & Johnson Medical, 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.

K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLEK982641ADVANCED NIBP MODULEK983362NU-GEL * WOUND DRESSINGK982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATEK974080CRITIKON SOFT BLOOD PRESSURE CUFFK980493I.V. CATHETER SYSTEM

View all 53 devices →

Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, 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.

↑