RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE— 510(k) K935842
Substantially EquivalentRusch, Inc.
FDA 510(k) clearance K935842 for RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE, Substantially Equivalent on 1995-05-23. Applicant: Rusch, Inc.. Device class: 2.
Clearance details
- Applicant
- Rusch, Inc.
- Product code
- Code BTR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Duluth, GA, US
Recent devices under product code BTR
view all- K251794 — Tenax® Laser Resistant Endotracheal Tube
- K253437 — Spiro-VISTA
- K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
- K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- K243579 — AeroJet Ventilation Catheter
More clearances from Rusch, Inc.
view allAdverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K935842
K-number listed on FDA's recall record- Z-2533-2020 — RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 ¿m to 10.6 ¿m.
- Z-1682-2019 — RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
- Z-1683-2019 — RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
- Z-1684-2019 — RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
- Z-1685-2019 — RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
- Z-1686-2019 — RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
- Z-1851-2014 — RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K935842.
Data sourced from openFDA. This site is unofficial and independent of the FDA.