510(k) K161514
- Device
- Precision Thin Reciprocating Blade, 0.010in.
- Applicant
- STRYKER CORPORATION
- 510(k) number
- K161514
- Product code
- EQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-01-17
- Date received
- 2016-06-02
- Regulation
- 874.4140
- Classification name
- Bur, Ear, Nose And Throat
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joanna McCarthy
- Address
- 4100 E. Milham Ave. Kalamazoo MI US 49009 49009
FDA Registration Numbers#
- 3042940336
- 3003687489
- 3005440795
- 2649614
- 9610617
- 3015967359
- 1526711
- 3005382983
- 1061124
- 3032391
- 8040278
- 9616696
- 9613926
- 9612501
- 1058322
- 3015453963
- 3010155648
- 1045834
- 1313525
- 3010163695
- 2648666
- 3010707607
- 1030489
- 3040335671
- 2083124
- 1032347
- 1625507
- 9610773
- 1928237
- 1836161
- 3010726901
- 3003800209
- 3011050570
- 9680837
- 3016678045
- 3006891611
- 1057421
- 3003418325
- 3003790304
- 3013893019
- 1058584
- 1526611
- 3013557562
- 2648623
- 3023464160
- 3005575604
- 1646747
- 3005333358
- 3010202439
- 1037007
- 3002809144
- 1824199
- 3014023545
- 3009460127
- 3013784566
- 3009417901
- 3001644167
- 1017294
- 3003120897
- 8010516
- 1058084
- 3014334038
- 3021632375
- 3008887731
- 1932180
- 3013247477
- 3005809810
- 3043648115
- 1045254
- 3003435550
- 2020550
- 1048735
- 3014342096
- 9611253
- 3018094310
- 1926681
- 3010173425
- 3004608878
- 1526534
- 3012494290
Source Documents#
Other 510(k) Records For Product Code EQJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041985 | XPS CURVED BUR | Medtronic Xomed, Inc. | 2004-08-12 |
| K974232 | ESSENTIAL SHAVER SYSTEM | Gyrus Ent LLC | 1998-01-12 |
| K960853 | ACE SYSTEM | Xomed, Inc. | 1996-04-03 |
| K955704 | TREBAY MICRODEBRIDER SYSTEM | Trebay Medical Corp. | 1996-01-30 |
| K955294 | SOF - ABRASION BUR | Trebay Medical Corp. | 1995-12-22 |
| K954912 | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | Trebay Medical Corp. | 1995-12-06 |
| K953370 | KARL STORZ ENT SHAVER | KARL STORZ Endoscopy-America, Inc. | 1995-09-06 |
| K950337 | KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL | KARL STORZ Endoscopy-America, Inc. | 1995-08-23 |
| K952609 | REDI DRILL DRILL SYSTEM | Trebay Medical Corp. | 1995-07-31 |
| K953096 | ESSENTIAL SHAVER SYSTEM | Smith & Nephew Richards, Inc. | 1995-07-28 |
| K946332 | KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION | KARL STORZ Endoscopy-America, Inc. | 1995-06-05 |
| K951526 | TREBAY IRRGATED CUTTER BLADE | Trebay Medical Corp. | 1995-05-12 |
| K935584 | MEDNEXT BUR | Mednext, Inc. | 1994-02-22 |
| K895738 | MICROMEDICS EAR, NOSE AND THROAT BURS | Micromedics, Inc. | 1989-12-19 |
| K893499 | CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS | Cmsi | 1989-11-16 |
Legacy Summary#
summary
FDA Review#
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