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FDA 510(k)

ACKRAD HYSTEROSALPINGOGRAPHY SET

K-Number: K842231 · 1984-09-19

ApplicantAckrad Laboratories
Decision Date1984-09-19
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ACKRAD HYSTEROSALPINGOGRAPHY SET is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1984-09-19 under 510(k) number K842231. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACKRAD HYSTEROSALPINGOGRAPHY SET?

ACKRAD HYSTEROSALPINGOGRAPHY SET is a medical device that received FDA 510(k) clearance on 1984-09-19. The listed applicant is Ackrad Laboratories. The 510(k) number is K842231.

When did ACKRAD HYSTEROSALPINGOGRAPHY SET receive FDA 510(k) clearance?

ACKRAD HYSTEROSALPINGOGRAPHY SET received FDA 510(k) clearance on 1984-09-19, under 510(k) number K842231.

Who is the listed applicant for ACKRAD HYSTEROSALPINGOGRAPHY SET?

The FDA 510(k) record lists Ackrad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACKRAD HYSTEROSALPINGOGRAPHY SET?

The FDA product code for ACKRAD HYSTEROSALPINGOGRAPHY SET is KNA.

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Other records listing Ackrad Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

View all 42 devices →

Related Devices (Code: KNA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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