COATED SUTURE NEEDLE— 510(k) K863595

Substantially Equivalent

Sharpoint, Inc.

FDA 510(k) clearance K863595 for COATED SUTURE NEEDLE, Substantially Equivalent on 1986-10-24. Applicant: Sharpoint, Inc.. Device class: 1.

Clearance details

Applicant: Sharpoint, Inc.
Product code: Code GAB
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-09-15
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAB

K012199 — DIGICAP2001-12-19
K980988 — AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)1998-05-11
K932591 — ENDO-JUDGE1993-12-22
K895681 — CONTRAST BACKGROUND MATERIAL1989-10-24
K831648 — ANCHOR BRAND SURGICAL NEEDLES1983-08-16

More clearances from Sharpoint, Inc.

K861947 — SURGICAL KNIFE1986-06-06
K840764 — EAR KNIVES1984-05-21
K840855 — CORNEAL SCLERAL LANCE1984-05-09
K840659 — ANTERIOR CAPSULECTOMY CYSTITOME1984-03-16
K840660 — POSTERIOR CAPSULOTOMY CYSTITOME1984-03-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.