Product code EFQ
- Device name
- Gauze/Sponge, Internal
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991757 | NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE | Furlong Industries | 1999-08-12 |
| K991215 | SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S | Symtex Healthcare Corp. | 1999-06-11 |
| K990974 | VITOP DRESSING | Wonder & Bioenergy Hi-Tech America, Inc. | 1999-06-09 |
| K990584 | GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE | Broadline Medical Industries | 1999-04-23 |
| K984187 | CROSSTEX NON-WOVEN SPONGES | Crosstex Intl. | 1999-02-18 |
| K983016 | GAUZE, SPONGES, CAT # 11-003 | Vitalcare Group, Inc. | 1999-02-12 |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | Dynarex Corp. | 1998-12-11 |
| K983450 | STARRYSHINE GAUZE SPONGE | T.C. Dental Products, Inc. | 1998-11-12 |
| K982648 | JOAN II | Celanese Acetate Co. | 1998-09-30 |
| K980791 | DUMEX PAK-ITS WOVEN RIBBON PACKING | Dumex Medical Surgical Products, Ltd. | 1998-04-29 |
| K974316 | HYDROFERA FEMORAL WICK | Hydrofera, LLC | 1998-02-13 |
| K974347 | BALDUR NON-STERILE COTTON SPONGES | Baldur Systems Corp. | 1998-02-10 |
| K973763 | KENDALL CURITY IODOFORM PACKING STRIP | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-12-31 |
| K973580 | INVOTEC CLEAN PAD | Invotec International, Inc. | 1997-12-10 |
| K973299 | PIN CARE KIT | Brown Medical Industries | 1997-11-26 |
| K971088 | OPPORTUNITY INCISION AND DRAINAGE TRAY | Opportunity, Inc. | 1997-09-16 |
| K971095 | OPPORTUNITY SUTURE REMOVAL KIT | Opportunity, Inc. | 1997-09-16 |
| K971178 | RAND SURGICAL SPONGE | Trans Aire | 1997-06-27 |
| K971075 | PRIMED PRIME-PLUS COTTON GAUZE SPONGES | Primeline Medical Products, Inc. | 1997-06-22 |
| K970457 | DUKAL ABD COMBINE PAD | Dukal Corp. | 1997-05-08 |
| K970455 | DUKAL NON ADHERENT DRESSING | Dukal Corp. | 1997-05-08 |
| K970020 | SIMAR, INC. SURGICAL DRESSING | Simar, Inc. | 1997-03-20 |
| K963724 | GAUZE SPONGE, NON X-RAY DETECTABLE | Grand Medical Products | 1996-11-29 |
| K960615 | GAUZE COMPRESS | Certified Safety Mfg., Inc. | 1996-11-25 |
| K963188 | DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) | Codi International BV | 1996-10-30 |
| K962972 | SURGICADE GAUZE SPONGE | Accunex Canada,Inc. | 1996-10-11 |
| K963134 | DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) | Igenics, Inc. | 1996-09-06 |
| K962227 | PRO-FECT STERILE GAUZE SPONGES | Network Trading Corp. Dba Grand Intl. | 1996-08-19 |
| K961773 | PROTEC STERILE GAUZE SPONGE | Derivadas Degasa S.A. DE C.V. | 1996-07-29 |
| K961775 | PROFORE FOUR-LAYER BANDAGE SYSTEM KIT | Smith & Nephew United, Inc. | 1996-07-16 |
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| 10192253047486 | Telfa | Cardinal Health 200, LLC | 2025-09-08 |
| 10192253047523 | Curity | Cardinal Health 200, LLC | 2023-10-09 |
| 10192253047561 | Curity | Cardinal Health 200, LLC | 2023-10-09 |
| 10850015055307 | Uline 25 Person First Aid Kit - SUB | ULINE, INC. | 2022-01-14 |
| 10850015055314 | Uline 50 Person First Aid Kit - SUB | ULINE, INC. | 2022-01-14 |
| 20681490105235 | MEROCEL® | MEDTRONIC XOMED, INC. | 2021-08-09 |
| 20681490105228 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105211 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105242 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105204 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105198 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105181 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105174 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105167 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105150 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 20681490105143 | MEROCEL® | MEDTRONIC XOMED, INC. | 2020-11-12 |
| 10612479136127 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-10 |
| 10612479136103 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-10 |
| 10612479136080 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-10 |
| 10612479136066 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-10 |
| 10885380052217 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-29 |
| 10885380052194 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-29 |
| 10885380052170 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-29 |
| 10885380052156 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-29 |
| 10884521068735 | Curity | Cardinal Health, Inc. | 2018-06-27 |
| 10884521068728 | Curity | Cardinal Health, Inc. | 2018-06-27 |
| 10884521068711 | Curity | Cardinal Health, Inc. | 2018-06-27 |
| 10884521068704 | Curity | Cardinal Health, Inc. | 2018-06-27 |
| 10885425499939 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-08-03 |