510(k) K951804
- Device
- KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- 510(k) number
- K951804
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-05
- Date received
- 1995-04-19
- 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
- MARIKA ANDERSON
- Address
- 600 Corporate Pt.e Culver City CA US 90230 90230
FDA Registration Numbers#
- 9616354
- 3030446844
- 3006546082
- 3002090132
- 3032391
- 3012322232
- 9613563
- 1519132
- 8010374
- 8030673
- 9614093
- 3003431869
- 3010402691
- 3017178358
- 3045058049
- 3005536872
- 3020460367
- 3006891796
- 1643116
- 3007647244
- 3004863697
- 3009420598
- 9681540
- 3016195092
- 9613079
- 9611112
- 9710567
- 3013901429
- 3003322138
- 9610773
- 1057358
- 1000379039
- 3003213883
- 3007597038
- 3004765453
- 3045010519
- 3012445994
- 3006154292
- 2243757
- 3005528784
- 9613073
- 3010202439
- 3027655341
- 3014498758
- 3042158672
- 3014342096
- 3001614464
- 3006087789
- 3007532396
- 3009255580
- 3004365956
- 8010418
- 3015895045
- 3009538961
- 3007583964
- 3004001706
- 3008808049
- 2434008
- 1036781
- 3021666757
- 3014233600
- 3005813597
- 3005092287
- 1928237
- 2025816
- 3015512299
- 3005698350
- 3004598675
- 3013528571
- 3036978610
- 3009429841
- 3012728206
- 3010829427
- 3005273623
- 2020550
- 3044186618
- 3014129616
- 9610691
- 3009703496
- 9681384
Source Documents#
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#
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