CRANIO BLADES AND WIRE PASS DRILL— 510(k) K861876

Clearance details

Applicant

New England Surgical Instrument Corp.

Product code

Code GFA

Device class

Class 1

Regulation

21 CFR 878.4820

Advisory panel

General, Plastic Surgery

Date received

1986-05-15

Decision date

1986-05-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rockland, MA, US

• K971978 — GRAFT HARVESTING SAWBLADES1997-06-18
• K954483 — STRYKER SAGITTAL SAW ATTACHMENT1996-01-30
• K955229 — WRIGHT MEDICAL TECHNOLOGY SAWBLADES1996-01-18
• K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS1995-07-12
• K950403 — SURGICAL SAW BLADES1995-02-21

• K895331 — ELECTROSURGICAL ELECTRODE1989-09-15
• K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE1989-09-15
• K883963 — RANEY AND LEROY-RANEY SCALP CLIP1988-10-07
• K883396 — HANDSWITCHING MONOPOLAR PENCIL1988-09-13
• K880863 — BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-12001988-04-19

Death

2

Injury

140

Malfunction

2,337

Total

2,479

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 →