SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE— 510(k) K862989

Name: FDA 510(k) clearance K862989
Creator: U.S. Food and Drug Administration
Published: 1986-08-21

Substantially Equivalent

Entronics

FDA 510(k) clearance K862989 for SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE, Substantially Equivalent on 1986-08-21. Applicant: Entronics. Device class: 2.

Clearance details

Applicant: Entronics
Product code: Code HBC
Device class: Class 2
Regulation: 21 CFR 882.4360
Advisory panel: Neurology
Date received: 1986-08-08
Decision date: 1986-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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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 Entronics

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K831946 — SURGICAL DRILL-ELECTRIC-HANDPIECE1983-11-03

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.