510(k) K191602
- Device
- APA Oxy Blade
- Applicant
- Venner Medical (Singapore) Pte Ltd
- 510(k) number
- K191602
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-08-02
- Date received
- 2019-06-17
- Regulation
- 868.5540
- Classification name
- Laryngoscope, Rigid
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Adrian P. Waterton
- Address
- 35 Joo Koon Cir. Singapore SG 629110 629110
FDA Registration Numbers#
- 8010374
- 3021031769
- 8021788
- 3010272829
- 3007481893
- 3013557562
- 3005273623
- 3010676356
- 3013358456
- 3009512503
- 3011499367
- 8010099
- 3004168759
- 3012843412
- 3014680906
- 3013528571
- 3009340886
- 3003431869
- 9614093
- 3012507533
- 1928237
- 3012002722
- 3010317211
- 3008770252
- 2183650
- 3010149039
- 3000279801
- 3004748541
- 3002858762
- 3007789561
- 3015139770
- 2030745
- 3010611926
- 3007123908
- 3009255580
- 9615393
- 3016195092
- 3010402691
- 3018094310
- 3006154292
- 3012322232
- 3010396739
- 3009669249
- 3015398570
- 3008388245
- 3014656749
- 3022320321
- 3006455037
- 3014129616
- 3021477808
- 1225968
- 9611102
- 9611283
- 9680837
- 8040884
- 3002807115
- 3003898360
- 3003924186
- 3006389770
- 3010707607
- 2936999
- 1836161
- 3005579585
- 3043585862
- 3007817051
- 1720747
- 3030516433
- 3004365956
- 3033010858
- 3012728206
- 3026201231
- 9613926
- 8010482
- 9617248
- 3007421149
- 3042158672
- 1926681
- 2410251
- 1314417
Source Documents#
Other 510(k) Records For Product Code CCW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) | Girgis Scope, LLC | 2017-06-22 |
| K140951 | YEESCOPE LARYNGOSCOPES | Yeescope Pty. , Ltd. | 2014-11-10 |
| K121378 | AIRTRAQ SP AIRTRAQ AVANT | Prodol Meditec , Ltd. | 2012-06-21 |
| K063477 | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET | Novamed, LLC | 2007-02-09 |
| K062523 | TRU-MR LARYNGOSCOPE SET | Truphatek International, Ltd. | 2006-11-17 |
| K062230 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 | Minrad, Inc. | 2006-08-31 |
| K062231 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 | Minrad, Inc. | 2006-08-31 |
| K041852 | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 | Minrad, Inc. | 2004-11-15 |
| K984101 | FLEXIBLADE | Arco Medic , Ltd. | 1999-09-03 |
| K971377 | GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE | Wilson Greatbatch Technologies, Inc. | 1998-04-30 |
| K970619 | GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE | Wilson Greatbatch Technologies, Inc. | 1997-11-19 |
| K945590 | SCOPETEX(TM) | Smith Helms Mulliss & Moore, L.L.P. | 1997-05-20 |
| K961832 | BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER | Blue Ridge Medical, Inc. | 1996-09-06 |
| K945301 | LARYNGOSCOPE COVER | Sotiria Mourkidou, M.D. | 1996-05-31 |
| K954787 | ILLUMINATOR | Hospitak, Inc. | 1996-01-31 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases