25-230 TO 25-390 VARIOUS NEEDLE HOLDERS— 510(k) K851780

Clearance details

Applicant

Artiberia

Product code

Code FHQ

Device class

Class 1

Regulation

21 CFR 876.4730

Advisory panel

Gastroenterology, Urology

Date received

1985-04-25

Decision date

1985-06-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Antonio, TX, US

• K974327 — WINGED NEEDLE HOLDER1998-01-09
• K924196 — LAPAROSCOPIC NEEDLE HOLDER1993-06-25
• K930330 — ENDOSCOPIC NEEDLEHOLDER, MODIFICATION1993-06-08
• K920706 — MAGNETIC POINT GUARD FOR SURGICAL NEEDLES1993-05-26
• K851779 — 25-100,25-220 VARIOUS NEEDLE HOLDERS1985-06-20

• K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B1985-08-29
• K851786 — 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF1985-07-09
• K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES1985-07-02
• K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS1985-07-02
• K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS1985-07-02

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →