510(k) K921263
- Device
- SUNLITE LARYNGOSCOPE
- Applicant
- SUNMED, INC.
- 510(k) number
- K921263
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-06-01
- Date received
- 1992-03-16
- Regulation
- 868.5540
- Classification name
- Laryngoscope, Rigid
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE CRANTON
- Address
- 5401 Tech Data Dr. Clearwater FL US 34620 34620
FDA Registration Numbers#
- 3030516433
- 3005528784
- 3003882387
- 3015139770
- 3026201231
- 3003924186
- 8010482
- 2182318
- 3008936260
- 2518436
- 3002807267
- 8010939
- 9680143
- 9611112
- 3021666757
- 3013687468
- 1722070
- 2529846
- 3003851906
- 3003032798
- 9680411
- 9610612
- 3007421149
- 9710567
- 3008264111
- 3022472
- 3006891796
- 3012797688
- 9680002
- 3031564283
- 3011307234
- 3020460367
- 3001620590
- 3008808049
- 3011137372
- 3010611926
- 3000279801
- 3004552850
- 3007123908
- 3004863697
- 3013735264
- 9614069
- 3006389770
- 8043903
- 3007532396
- 3006513362
- 9615393
- 3012507533
- 9610773
- 3010353847
- 3003790304
- 3004215117
- 2022648
- 1720747
- 3004365956
- 9616354
- 1519132
- 1421101
- 3011499367
- 3032747418
- 3008388245
- 3009340886
- 2432320
- 9681622
- 9610531
- 9612074
- 3005273623
- 3006455037
- 3020984207
- 3030733800
- 3013247477
- 3014656749
- 3010707607
- 8010704
- 3016734145
- 1417592
- 3012322232
- 3003435550
- 3000126234
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CCW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191602 | APA Oxy Blade | Venner Medical (Singapore) Pte, Ltd. | 2019-08-02 |
| 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 |
Legacy Summary#
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FDA Review#
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