Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 46
- Latest Decision
- 1978-12-04
Clearances · page 154 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K781575 | DISPOSABLE LYMPHANGIOGRAM SET | Instranetics, Inc. | FPA | Class II | 1978-12-04 |
| K781917 | MUCUS ASPIRATOR | Ovutime, Inc. | FMF | Class II | 1978-12-04 |
| K780340 | IMV SYSTEM | Lkb Instruments, Inc. | CBD | Class II | 1978-11-27 |
| K781924 | POUCHES AND TUBING, MEDI-SEAL | Medicare Industries, Inc. | FRG | Class II | 1978-11-22 |
| K781589 | VOLUMETRIC CONTROLLER MODEL 310 | Imed Corp. | FLN | Class II | 1978-11-22 |
| K781925 | POUCHES, GAS STERILIZATION | Medicare Industries, Inc. | FRG | Class II | 1978-11-22 |
| K781087 | MEDICAL GRADE SILICONE ELASTOMER TUBING | Mcghan Medical Corp. | FPK | Class II | 1978-11-22 |
| K781791 | BOARD, DISPOSABLE CONTROL COUNT | Dexide, Inc. | MMK | Class II | 1978-11-08 |
| K781717 | MONITOR, GRAVITY IRRIGATION DRIP | Syntel, Inc. | FLN | Class II | 1978-10-27 |
| K781484 | CASTLE MODEL 3146 GAS AERATOR | Castle Co. | FLI | Class II | 1978-10-27 |
| K781297 | INTRA-ALERT | Pan-Tech Research, Inc. | FLN | Class II | 1978-10-25 |
| K781699 | EAGLE PAC/VISIBLE SEAL | American Sterilizer Co. | KCT | Class II | 1978-10-24 |
| K781684 | STERILIZER, EAGLE 2000 | American Sterilizer Co. | FLE | Class II | 1978-10-24 |
| K781354 | PILLOWS- SINGLE PATIENT USE | Abco Dealers, Inc. | KME | Class I | 1978-10-17 |
| K781364 | PINT BOTTLE WELL | Baxa Corp., Sub. of Cook Group, Inc. | KYX | Class I | 1978-10-17 |
| K781227 | TOWELS, SHEETS, PILLOWCASES | Abco Dealers, Inc. | KME | Class I | 1978-10-17 |
| K781661 | THERMOMETER, DIGITAL ELEC. MODEL 4755 | British Aerospace, Inc. | FLL | Class II | 1978-10-17 |
| K780719 | FUNGUS FIGHTER INSOLES | Combe, Inc. | KYS | Class I | 1978-10-10 |
| K781127 | CONNECTING TUBE, CONDUCTIVE, SURG. | Seamless Hospital Products Co. | GAZ | Class II | 1978-09-20 |
| K781037 | PRESSURE INFUSION DEVICE | Hinck Medical, Inc. | KZD | Class I | 1978-09-14 |
| K781228 | PENLIGHTS | Abco Dealers, Inc. | KYT | Class I | 1978-09-07 |
| K781404 | BED PADS: D-12 AND D-8 | Grant Airmass Corp. | FNM | Class II | 1978-09-07 |
| K781406 | HYDRON BURN BANDAGE MANUAL APPLICATION | Abbott Laboratories | KMF | Class I | 1978-09-07 |
| K781278 | GLOVES, PROCEDURE | Arbrook Mfg. Corp. | FMC | Class I | 1978-08-31 |
| K781279 | SUCTION CANISTER | Abco Dealers, Inc. | KDQ | Class II | 1978-08-10 |
| K781136 | TEMPERATURE MODULE, DUAL | Cavitron Corp. | FLL | Class II | 1978-08-10 |
| K781301 | WRAP, STERILIZATION | Stanford Professional Products | FRG | Class II | 1978-08-10 |
| K781246 | FOAM COMFORT RINGS | Fibre Formations, Inc. | FMP | Class I | 1978-08-10 |
| K781189 | FLU VEN 0151 | Venospital, Inc. | FPA | Class II | 1978-08-10 |
| K781185 | INFUSION SET W/ INJECTION SITE | Venospital, Inc. | FPA | Class II | 1978-08-10 |
| K781190 | INFUSION SET, VENOTHIN 21 | Venospital, Inc. | FPA | Class II | 1978-08-10 |
| K781171 | INFUSION PUMP, PEDIATRIC MODEL 301 | Imed Corp. | FRN | Class II | 1978-08-10 |
| K781184 | INFUSION SET, VENOTHIN 19 | Venospital, Inc. | FPA | Class II | 1978-08-10 |
| K781188 | INFUSION SET, VENOTHIN 25 | Venospital, Inc. | FPA | Class II | 1978-08-10 |
| K781186 | INFUSION, VENOTHIN 23 | Venospital, Inc. | FPA | Class II | 1978-08-10 |
| K780906 | AIR-FLO ALTERNATING PRESSURE PAD SYSTEM | Gaymar Industries, Inc. | FNM | Class II | 1978-08-10 |
| K781154 | SYRINGE, INSULIN, HYPOTIP | National Patent Development Corp. | FMF | Class II | 1978-08-10 |
| K780861 | ELECTRONIC CLINICAL THERMOMETER | Trend Medical, Inc. | FLL | Class II | 1978-08-10 |
| K780884 | HYPO-GRIP | Harco Products | KZA | Class I | 1978-08-10 |
| K781234 | TUBES, LUKENS, TOMAS | Ludwig Medical, Inc. | KDQ | Class II | 1978-08-10 |
| K781106 | THERMOMETER, EXACTA TEMP | S.M.B. Celsius Co., Inc. | FLK | Class II | 1978-08-10 |
| K781312 | THERMOMETER, MODEL 49TA | Yellow Springs Instrument Co., Inc. | FLL | Class II | 1978-08-10 |
| K781187 | INFUSION SET W/ INJECTION SITE, 23D-W | Venospital, Inc. | FPA | Class II | 1978-08-10 |
| K781036 | AUTO-SYRINGE INFUSION SET | Baxter Healthcare Corp | FPA | Class II | 1978-08-10 |
| K780883 | E-Z-JECTOR | Harco Products | KZA | Class I | 1978-08-10 |
| K781031 | AEROPLAST DRESSING | Parke-Davis Co. | KMF | Class I | 1978-07-27 |
| K780974 | BACILLUS PUMILUS | Urol, Inc. | FRL | Class I | 1978-07-27 |
| K780964 | TRANSPORT INCUBATOR | Cavitron Corp. | FPL | Class II | 1978-07-27 |
| K780794 | IRRIGATION CAP | Travenol Laboratories, S.A. | KYZ | Class I | 1978-07-27 |
| K780970 | BURETTE SET WITH AIR CONTROL LEVER | Travenol Laboratories, S.A. | FPA | Class II | 1978-07-27 |
| K780985 | PVC LINES FOR MONITORING | Norton Performance Plastics Corp. | GAZ | Class II | 1978-07-27 |
| K780657 | STERILE BLOOD COLLECTION SET | Suru Chemicals & Pharmaceuticals, Ltd. | FPA | Class II | 1978-07-19 |
| K780655 | STERILE INFUSION SET TYPE S | Suru Chemicals & Pharmaceuticals, Ltd. | FPA | Class II | 1978-07-19 |
| K780656 | STERILE INFUSION SET TYPE J | Suru Chemicals & Pharmaceuticals, Ltd. | FPA | Class II | 1978-07-19 |
| K780658 | STERILE BLOOD ADMINISTRATION SET | Suru Chemicals & Pharmaceuticals, Ltd. | FPA | Class II | 1978-07-19 |
| K780565 | SUTURELESS SKIN CLOSURE | Abbott Laboratories | FPX | Class I | 1978-07-07 |
| K780929 | COTTON TIPPED POINT | Young Dental Manufacturing Co. 1, LLC | KXF | Class I | 1978-06-30 |
| K780662 | SUPPLEMENTAL TYGON PAC-MONITORING LINES | Norton Performance Plastics Corp. | FMG | Class II | 1978-06-06 |
| K780628 | HALOGEN EXAM. LITE #48400 | Welch Allyn, Inc. | KZF | Class I | 1978-06-06 |
| K780684 | PATIENT LIFT | Orthopedic Equipment Co., Inc. | FSA | Class I | 1978-06-06 |
| K780559 | DISPOSABLE INFUSION SET | Ks Medical Supply Co. | FPA | Class II | 1978-06-06 |
| K780593 | PROBE COVER | Abco Dealers, Inc. | FLL | Class II | 1978-06-06 |
| K780608 | ICE BAG, VINYL | Abco Dealers, Inc. | KYR | Class I | 1978-06-06 |
| K780800 | ELECTRONIC THERMOMETER | Metek Corp. | FLL | Class II | 1978-06-06 |
| K780724 | BUBBLE SUCTION TUBING | Davol, Inc. | BYY | Class II | 1978-06-02 |
| K780465 | VOLUME CONTROL DEVICE VCD-150 | Sorensen Research | KZD | Class I | 1978-06-02 |
| K780779 | ECONO-FLOAT WATER FLOTATION MATTRESS | Jefferson Industries, Inc. | IKY | Class I | 1978-05-19 |
| K780705 | INFUSION PUMP-MODEL 2616 | Harvard Apparatus, Inc. | FRN | Class II | 1978-05-19 |
| K780673 | CENTRAL CATHETER KIT | Argon Medical Corp. | FPK | Class II | 1978-05-16 |
| K772424 | RYUSEI | Ercona Corp. | BWJ | Class II | 1978-05-09 |
| K780580 | TEMPERATURE INDICATOR | Respiratory Care, Inc. | KPD | Class II | 1978-04-27 |
| K780602 | SYRINGE (IRRIGATION) | Abco Dealers, Inc. | FMF | Class II | 1978-04-19 |
| K780591 | THERMOMETER KIT | Abco Dealers, Inc. | FLK | Class II | 1978-04-19 |
| K780606 | BANDAGE | Abco Dealers, Inc. | FQM | Class I | 1978-04-19 |
| K780600 | IRRIGATION TRAY | Abco Dealers, Inc. | FMF | Class II | 1978-04-19 |
| K780551 | I.V. ADMINISTRATION SET WITH MINI-SPIKE | National Patent Development Corp. | FPA | Class II | 1978-04-19 |
| K780550 | STERILE AIR SYRINGE | National Patent Development Corp. | FMF | Class II | 1978-04-19 |
| K780616 | HYDRON BURN DISPOSABLE DISPENSER SET | Abbott Laboratories | KMF | Class I | 1978-04-19 |
| K780604 | SHAVE PREP | Abco Dealers, Inc. | KXF | Class I | 1978-04-19 |
| K780595 | MINI-IRRIGATION TRAY | Abco Dealers, Inc. | FMF | Class II | 1978-04-19 |
| K780570 | TUBULAR DRESSING RETAINER | Alba-Waldensian, Inc. | FQM | Class I | 1978-04-19 |
| K780596 | STOPCOCK | Abco Dealers, Inc. | FMG | Class II | 1978-04-19 |
| K780472 | INFANT INCUBATOR | Air-Shields, Inc. | FMZ | Class II | 1978-04-19 |
| K780417 | ASEPTIC TRANSFER SET | Heyer Schulte Corp. | GAZ | Class II | 1978-04-18 |
| K780223 | PARENTERAL INFUSION CONTROLLER | Travenol Laboratories, S.A. | FLN | Class II | 1978-04-10 |
| K780503 | INFUSION PUMP | Air-Shields, Inc. | FRN | Class II | 1978-04-10 |
| K780371 | TILT TYPE AC POWERED HOSPITAL BED | Medical Specialty Products, Inc. | FNL | Class II | 1978-04-10 |
| K780370 | STAND UP TOILET | Medical Specialty Products, Inc. | FOB | Class I | 1978-04-10 |
| K780131 | THERMOMETER, DIGITAL, NTM-100 | Wilton Webster Laboratories | FLL | Class II | 1978-04-10 |
| K780418 | BURN DRESSING PAD | The Owenby Co. | FPY | Class I | 1978-04-10 |
| K780209 | DILUTION SPIKE | Sterling Drug, Inc. | FMI | Class II | 1978-04-10 |
| K780502 | NOVA AIR FLOATATION SYSTEM | Nova Health Systems, Inc. | FNM | Class II | 1978-04-10 |
| K780481 | I.V. LEVER CLAMP | Travenol Laboratories, S.A. | FPA | Class II | 1978-04-10 |
| K780294 | G WRAP | Cel-Fibe | FRG | Class II | 1978-03-28 |
| K780350 | I.V. START KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | FOZ | Class II | 1978-03-27 |
| K780396 | NASAL GASTRIC TUBE RETAINER | Mor-Mac, Inc. | FPK | Class II | 1978-03-22 |
| K772276 | RAISED TOILET SEAT | Med Fusion Systems, Inc. | LDQ | 1978-03-14 | |
| K772275 | TOILET SAFETY RAIL | Med Fusion Systems, Inc. | LDQ | 1978-03-14 | |
| K780260 | TEMP. SENSOR W/22MM FITTINGS | Bd Becton Dickinson Vacutainer Systems Preanalytic | KPD | Class II | 1978-03-14 |
| K772298 | SEXUAL ASSAULT FORENCIC EVIDENCE KIT | Simpson/Basye, Inc. | KXF | Class I | 1978-03-02 |
15,723 clearances in the General Hospital panel. Data: openFDA.