BRONCHOSCOPY TUBE W/ULTRA LOCUFF— 510(k) K833297

Name: FDA 510(k) clearance K833297
Creator: U.S. Food and Drug Administration
Published: 1983-12-27

Substantially Equivalent

Surgitek

FDA 510(k) clearance K833297 for BRONCHOSCOPY TUBE W/ULTRA LOCUFF, Substantially Equivalent on 1983-12-27. Applicant: Surgitek. Device class: 2.

Clearance details

Applicant: Surgitek
Product code: Code BTS
Device class: Class 2
Regulation: 21 CFR 868.5720
Advisory panel: Anesthesiology
Date received: 1983-09-23
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTS

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K953963 — RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION1995-11-27
K951091 — RUSCH ENDOBRONCHIAL TUBE SETS1995-06-08
K902116 — MODIFIED ENDOBRONCHIAL TUBE1990-08-03
K834565 — ENDOBRONCHIAL TWIN LUMEN TUBE1984-01-17
K771219 — BRONCHO-CATH1977-08-04

More clearances from Surgitek

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K946296 — QUADRA-COIL URETERAL STENT1995-03-06
K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM1995-02-07
K943491 — RIGHT ANGLE UROLOGIC LASER FIBER1994-08-05
K941952 — SURGITEK INFUSER1994-05-24
K933260 — HELICAL STONE/FLATWIRE STONE BASKETS1994-01-11

Adverse events under product code BTS

product code BTS

Death: 2
Malfunction: 877
Total: 879

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.