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FDA 510(k)

DISPOSABLE PNEUMOPERITONEUM NEEDLE

K-Number: K863330 · 1986-10-02

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1986-10-02
Product CodeFHO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PNEUMOPERITONEUM NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1986-10-02 under 510(k) number K863330. The device is classified under product code FHO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE PNEUMOPERITONEUM NEEDLE?

DISPOSABLE PNEUMOPERITONEUM NEEDLE is a medical device that received FDA 510(k) clearance on 1986-10-02. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K863330.

When did DISPOSABLE PNEUMOPERITONEUM NEEDLE receive FDA 510(k) clearance?

DISPOSABLE PNEUMOPERITONEUM NEEDLE received FDA 510(k) clearance on 1986-10-02, under 510(k) number K863330.

Who is the listed applicant for DISPOSABLE PNEUMOPERITONEUM NEEDLE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE PNEUMOPERITONEUM NEEDLE?

The FDA product code for DISPOSABLE PNEUMOPERITONEUM NEEDLE is FHO.

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Other records listing United States Surgical, A Division of Tyco Healthc as applicant

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Related Devices (Code: FHO)

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.

K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,LtdK121370VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLEVectecK010779MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTGibbons Surgical Corp.K970788PNEUMO-MATIC INSUFFLATION NEEDLEApple Medical Corp.K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMSherwood Medical Co.K951894ACCESS EXPANSION SYSTEMMicro-Medical Devices, 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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