450/800 DRILL— 510(k) K812436

Name: FDA 510(k) clearance K812436
Creator: U.S. Food and Drug Administration
Published: 1981-11-02

Substantially Equivalent

Black & Decker(Tm)

FDA 510(k) clearance K812436 for 450/800 DRILL, Substantially Equivalent on 1981-11-02. Applicant: Black & Decker(Tm). Device class: 2.

Clearance details

Applicant: Black & Decker(Tm)
Product code: Code HBC
Device class: Class 2
Regulation: 21 CFR 882.4360
Advisory panel: Neurology
Date received: 1981-08-26
Decision date: 1981-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HBC

view all

K254174 — Surgical Power System2026-09-11
K233153 — Traus SSG10 Surgical System2024-09-20
K232938 — Traus SSG30 Surgical System2024-09-16
K213697 — ORiGO System2022-10-31
K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)2022-05-19

More clearances from Black & Decker(Tm)

view all

K820351 — CAST CUTTER/CAST SAW/INSTRUMENT1982-03-02
K812437 — 150 DRIVER REAMER1981-11-02
K812438 — SAGITTAL SAW1981-11-02
K812439 — DUAL MPC CHARGER1981-11-02
K812440 — POWER PACK1981-11-02

Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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 →

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