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FDA 510(k)

NOTCH-NEEDLE, WESCOTT STYLE

K-Number: K870896 · 1987-03-18

ApplicantOcean Medical Products, Ltd.
Decision Date1987-03-18
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOTCH-NEEDLE, WESCOTT STYLE is the device name listed in this FDA 510(k) record. The listed applicant is Ocean Medical Products, Ltd.. It received FDA 510(k) clearance on 1987-03-18 under 510(k) number K870896. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOTCH-NEEDLE, WESCOTT STYLE?

NOTCH-NEEDLE, WESCOTT STYLE is a medical device that received FDA 510(k) clearance on 1987-03-18. The listed applicant is Ocean Medical Products, Ltd.. The 510(k) number is K870896.

When did NOTCH-NEEDLE, WESCOTT STYLE receive FDA 510(k) clearance?

NOTCH-NEEDLE, WESCOTT STYLE received FDA 510(k) clearance on 1987-03-18, under 510(k) number K870896.

Who is the listed applicant for NOTCH-NEEDLE, WESCOTT STYLE?

The FDA 510(k) record lists Ocean Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOTCH-NEEDLE, WESCOTT STYLE?

The FDA product code for NOTCH-NEEDLE, WESCOTT STYLE is GAA.

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 Ocean Medical Products, Ltd. 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.

K882013SOFT TISSUE BIOPSY DEVICEK843719SINGLE WALL INTRODUCER NEEDLEK823693MYELOGRAPHY NEEDLEK823692SPINAL NEEDLEK813462MADAYAG TYPE NEEDLEK813448POTTS-COURNAND STYLE NEEDLE

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Related Devices (Code: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, 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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